FDA Compliance & Validation Solution for Compound Pharmacies
Services that Ensure Compliance with FDA Requirements
FDA Compliance & Validation ServicesOperational Compliance and Risk Management for Compound Pharmacies
Since 2012, the requirements and regulations surrounding Compounding Pharmacies have changed dramatically, resulting in many facilities with a desire to meet these regulations, but not sure where to begin. Let CSA help guide you through these steps by developing risk management solutions that will result in quick and effective compliance.
Our team is ready to assist with understanding the requirements under FD&C Act 503 (a) and 503 (b) along with the most current regulations and how they would apply to your facility. We are able to guide you and your team through the process and give recommendations for any changes that may need to be made to your facility, equipment and/or process. Our staff has extensive knowledge and experience of production in Current Good Manufacturing Practices (cGMP) environments and can work to guide and required changes to may be needed. CSA employs a risk based approach to ensure that any changes needed will be implemented efficiently, while ensuring compliance with the FDA requirements.
Equipment and Facility Qualification
We offer equipment and facility qualification services that maximize efficiency while ensuring compliance with the FDA‘s expectations for validation. By focusing equipment and facility validation testing on intended usage and combining it with other validation tasks such as commissioning and controls, we can significantly improve efficiency and reduce the validation timeline. Our staff has the applied industry experience and technical background to define equipment requirements, develop and execute test protocols and tie equipment compliance into the scope of your process validation requirements. We provide a wide range of equipment qualification services that satisfy the FDA’s expectations for equipment and facility compliance. We support new and legacy equipment and facilities and work closely with your team to ensure equipment is designed and installed according to your specific process requirements.
There are many interpretations of process validation, but most experts view it as the final step in the process development cycle that ensures production is accurate and consistent over time. CSA provides a modified approach that uses risk management to analyze the process as a whole rather than a collection of discrete pieces, regardless of the size of the operation. Once the risks are understood, this data can be used to remove redundancies and justify reducing tests that are of little value Our engineers work with your team to understand and document each step of the process in order to provide an approach for FDA compliance suitable to your needs. From this understanding, we can also offer suggestions for process analytical techniques and monitoring for even greater control, if needed.
A number of current issues, including catastrophic production of materials from compounding pharmacies, have led cleaning processes to receive heightened scrutiny from the FDA. Cleaning validation studies are even more important when it isn’t feasible to use dedicated equipment for a given process or product. But how clean is clean enough? And how much sampling is needed to demonstrate cleanliness? These are not easy questions to answer, even for process experts. Our engineering and science professionals understand the criticality of cleaning processes and through careful design and analysis can help you ensure the effectiveness of yours. We provide expert guidance in establishing validation test protocols, setting residue and cleanliness acceptance criteria, developing sampling plans and working with either your laboratory or a third party to ensure test methodology is adequately sensitive and accurate.
Computer System Validation
Computer systems are a critical part of modern operational processes. But despite their ubiquity, many systems must be uniquely designed or configured to meet the specific needs of a business. When deployed in a GMP environment, these unique characteristics can be a challenge to validate in a manner that is both FDA compliant and efficient. Given the high cost of software, hardware and deployment, no one wants to spend even more time and money than necessary on a lengthy validation project. Since one size doesn’t fit all when it comes to operational compliance, we employ risk management and process analysis techniques to tailor the validation effort specifically to your business. These powerful techniques maximize the value of FDA mandated computer system validation by identifying critical steps and functions, and focusing tests on what really matters to your process.